Life Sciences

April 25, 2025
Aggressive USPTO Policy Push Suggests 'It's Lutnick's Show'

U.S. Patent and Trademark Office acting Director Coke Morgan Stewart's three months in charge have featured an unprecedented level of policymaking for an interim leader, suggesting that Secretary of Commerce Howard Lutnick has a vision for the agency and he's not waiting for the U.S. Senate to confirm a new director to pursue it.
April 25, 2025
Ozempic Maker Settles Infringement Claims With Atlanta Clinic

Novo Nordisk, the pharmaceutical manufacturer behind Ozempic and other weight loss drugs, said Friday it has reached a settlement to end a series of claims that a Georgia anti-aging clinic was using the company's name and reputation to sell off-brand versions of its treatments.
April 25, 2025
Insulet's $452M Trade Secrets Award Reduced To $59.4M

A $452 million trade secrets jury award for Insulet Corp. has been cut to $59.4 million by a Massachusetts federal judge who said the reduction is necessary to avoid double recovery and to comply with the law, following a trend where courts have reduced large jury awards in trade secret cases.
April 25, 2025
11th Circ. Backs FDA In Denial Of Bidi's Vape Application

The Eleventh Circuit has affirmed the denial of a marketing application for a tobacco-flavored electronic cigarette made by Bidi Vapor LLC, finding that the U.S. Food and Drug Administration did not act arbitrarily or capriciously in finding that the company failed to show the product would promote public health.
April 24, 2025
Circuit-By-Circuit Guide As Justices Confront Class Cert. Split

The U.S. Supreme Court is set for climactic arguments over class certification standards that have cleaved circuits from coast to coast for much of the past two decades, teeing up a make-or-break ruling for many class actions and a transformative event for legal practice in the swelling litigation realm.
April 24, 2025
Biz Court Questions What Ties TikTok To NC In Addiction Case

A North Carolina business judge grappled Thursday with the limits of personal jurisdiction in the internet age in the state's case alleging TikTok addicts young users, questioning whether a digital app is different from a physical good regarding where a lawsuit can be filed.
April 24, 2025
DOJ Probing Disney-FuboTV Deal, And Other Rumors

The DOJ is investigating Disney's proposed FuboTV acquisition, Merck is close to a $3.5 billion deal for SpringWorks, and U.S. investor James Cameron offered $5 billion for a Luxembourg-based mining enterprise. Here, Law360 breaks down these and other notable deal rumors from the last week.
April 24, 2025
Polsinelli Gains 2 Healthcare Shareholders In Denver

Polsinelli PC announced this week that it has brought two Denver-based attorneys from Husch Blackwell LLP and the U.S. Food and Drug Administration to its healthcare practice, which the firm says gained six new shareholders in the past 12 months, not including these most recent additions.
April 24, 2025
Harvard Seeks To Move 'Swiftly' In $2B Fund Freeze Suit

Harvard University is seeking to move as quickly as possible to get to the merits of its suit challenging the Trump administration's $2.2 billion funding freeze, asking a Massachusetts federal judge to expedite discovery and briefing.
April 24, 2025
UPS Paying $1.6B For Andlauer's Healthcare Logistics Co.

UPS said Thursday it has agreed to acquire Andlauer Healthcare Group Inc. for approximately 2.2 billion Canadian dollars ($1.6 billion) in cash, expanding its global healthcare logistics footprint with a particular focus on so-called cold chain capabilities.
April 24, 2025
Latham-Led LLR Clinches 7th Fund With $2.45B Committed

Latham & Watkins LLP-advised LLR Partners on Thursday announced that it wrapped its seventh private equity fund with $2.45 billion in tow.
April 23, 2025
11th Circ. Considers Timeliness Of J&J Pelvic Mesh Claims

An Alabama couple urged the Eleventh Circuit on Wednesday to revive their lawsuit over injuries allegedly caused by pelvic mesh manufactured by Ethicon Inc. and its parent Johnson & Johnson, arguing that a district court wrongly found their claims were time-barred.
April 23, 2025
FDA Warns Of Health Risks In Topical Hair Loss Drug

The U.S. Food and Drug Administration on Wednesday alerted healthcare providers, pharmaceutical compounders and consumers about potential safety risks tied to certain hair loss treatment products, citing reports of persistent adverse side effects, including sexual dysfunction, depression and suicidal thoughts.
April 23, 2025
Curaleaf Sues Ex-VP For Alleged Breach Of Noncompete

Cannabis company Curaleaf sued a former executive in Florida federal court Wednesday, alleging she breached her employment agreement and may have shared confidential information when she jumped ship to competitor Jushi.
April 23, 2025
Fed. Circ. Agrees MS Generic Drug Didn't Infringe Metacel IP

The Federal Circuit on Wednesday backed a New Jersey federal judge's finding that Rubicon Research's generic version of Metacel's drug Ozobax does not induce doctors and patients to infringe a Metacel patent.
April 23, 2025
Ex-Sprinter Turned Track Coach Cops To Olympic Doping Rap

A onetime world-class sprinter from Georgia on Wednesday admitted to illegally providing banned performance-enhancement drugs while training athletes to compete in the 2020 Tokyo Olympic Games.
April 23, 2025
Law Firm Fights Sanctions Bid In Mootness Fee Row

Attorneys at Monteverde & Associates PC urged an Illinois federal judge not to order certain sanctions against them in a challenge to so-called mootness fees paid to settle and dismiss allegedly baseless merger disclosure suits, saying more sanctions would be inconsistent with "well-established" pleading and sanctions standards.
April 23, 2025
Ex-Exec Says Centene Harassed Him Over Void Noncompete

A former vice president at Centene claims in a new Illinois federal court lawsuit that the company has engaged in a campaign of harassment, threats and bullying directed at him and his new employer, based on a noncompete agreement he alleges is void.
April 23, 2025
Judge Lifts Biocon Eye Med Biosimilar Ban After Settlement

A West Virginia federal judge has vacated a permanent injunction that had blocked Biocon Biologics Inc. from selling a biosimilar to Regeneron's blockbuster eye medication Eylea in the U.S., citing a settlement agreement in the patent litigation allowing sales of the biosimilar in 2026.
April 23, 2025
Sandoz, Novartis Cut Price-Fixing Deal With South Carolina

Sandoz Inc. and Fougera Pharmaceuticals Inc. have struck a deal with the state of South Carolina to resolve claims that they and Sandoz's former parent company, Novartis AG, engaged in a price-fixing conspiracy to inflate the price of certain generic drugs.
April 23, 2025
Genetic Testing Co., Marketer Settle FCA Case For $6M

A genetic testing company, marketing firm, and their top executives have agreed to pay $6 million to resolve the government's allegations that they billed Medicare for unnecessary medical tests, in violation of the False Claims Act.
April 23, 2025
FCA Suit Over Allergan's Alleged Kickbacks Trimmed

An Illinois federal judge on Wednesday pared down a lawsuit by former Allergan USA pharmaceutical sales reps claiming the company engaged in a scheme to provide kickbacks to doctors in exchange for prescribing more gastrointestinal drugs, saying they largely failed to show enough of a link between the alleged kickbacks and any false claims to the government for prescriptions.
April 23, 2025
Eli Lilly Sues 4 Telehealth Cos. For Weight Loss Drug Copies

Eli Lilly filed a new round of lawsuits Wednesday over the compounding of its popular weight loss drugs Mounjaro and Zepbound, accusing four telehealth companies of making copies of the medications while alleging that two companies violated laws requiring doctors to make medical decisions, not corporations.
April 23, 2025
M&A 'Pause' Requires Nimble, Creative Dealmaking

With deals stalling in a market defined by uncertainty, attorneys and the dealmakers they counsel are leaning on creative structures — from earnouts to partial stake sales — to keep transactions alive, according to corporate lawyers advising on major mergers and acquisitions.
April 23, 2025
Swiss Drug Developer Veraxa To List In US In $1.6B SPAC Deal

Swiss life sciences investor Xlife Sciences said Wednesday that its portfolio company, Veraxa Biotech, will merge with blank-check business Voyager Acquisition Corp. in a $1.64 billion deal to list on Nasdaq.

Editor's Picks

Supreme Court Will Tackle Patent Enablement In Amgen Case

The U.S. Supreme Court on Friday agreed to review Section 112 of the Patent Act for the second time in the law's history, accepting Amgen's request to consider how much a patent must disclose in order to meet enablement requirements.
A Circuit-By-Circuit Guide To FCA Suits After High Court Snub

The U.S. Supreme Court's refusal to resolve one of the False Claims Act's most consequential controversies leaves circuit courts deeply divided over whistleblower pleading obligations in ways that will reverberate nationwide, attorneys say. Here, Law360 explores each circuit's approach and scenarios that might finally trigger high court intervention.
Inside The Collapse Of A Pioneering Opioid Case For DOJ

The U.S. Department of Justice launched a "terribly flawed" criminal case against a drug distributor and several individuals amid pressure to alleviate Appalachia's opioid crisis, and a newly confirmed U.S. attorney displayed "courage and guts" by ending the case last month, defense counsel told Law360 in an expansive interview.

Expert Analysis

Reproductive Health Under Trump So Far, And What's Next

Based on priorities stated so far, the Trump administration will likely continue to weaken Biden-era policies that protect reproductive health, with abortion, in vitro fertilization and contraception all being issues to watch closely amid a post-Dobbs shift, say attorneys at McDermott.
Series

Playing Football Made Me A Better Lawyer

While my football career ended over 15 years ago, the lessons the sport taught me about grit, accountability and resilience have stayed with me and will continue to help me succeed as an attorney, says Bert McBride at Trenam.
10 Arbitrations And A 5th Circ. Ruling Flag Arb. Clause Risks

The ongoing arbitral saga of Sullivan v. Feldman, which has engendered proceedings before 10 different arbitrators in Texas and Louisiana along with last month's Fifth Circuit opinion, showcases both the risks and limitations of arbitration clauses in retainer agreements for resolving attorney-client disputes, says Christopher Blazejewski at Sherin and Lodgen.
Keys To Handling Digital Investigations In Pharma IP Litigation

In the high-stakes realm of pharmaceutical intellectual property litigation, efficient e-discovery and digital investigation workflows are essential to supporting strategic arguments, building defensible cases and proving that the requirements for market entry have been adequately met, says Jerry Lay at FTI Consulting.
Perspectives

The Benefits Of Aligning States On Legal Paraprofessionals

Texas' proposal to become the latest state to license paraprofessional providers of limited legal services could help firms expand their reach and improve access to justice, but consumers, attorneys and allied legal professionals would benefit even more if similar programs across the country become more uniform, says Michael Houlberg at the University of Denver.
What's Next For Lab Test Regulation Without FDA Authority

A recent Texas federal court decision vacating the U.S. Food and Drug Administration's final rule that would apply FDA regulations to laboratory-developed tests signals potential positive impacts in the diagnostic space, and could inspire more healthcare entities to litigate against the government, say attorneys at Hooper Lundy.
10 Soft Skills Every GC Should Master

As businesses face shifting regulatory and technological uncertainty, general counsel will need to strengthen certain soft skills to succeed, from admitting when they make a mistake to maintaining a healthy dose of dispassion, says Douglas Brown at Manatt.
6 Criteria Can Help Assess Executive Branch Actions

With new executive policy changes announced seemingly every day, several questions can help courts, policymakers and businesses determine whether such actions are proper, effective and in keeping with our democratic norms, say Marc Levin and Khalil Cumberbatch at the Council on Criminal Justice.
An Unrestrained, Bright-Eyed View Of Legal AI's Future

Todd Itami at Covington offers a bright-eyed, laughing-all-the-way, skydive look at what the legal industry could look like after an artificial intelligence revolution, which he believes may happen much sooner and more dramatically than we expect.
Tracking The Evolution In Litigation Finance

Despite continued innovation, litigation finance remains an immature market with borrowers recieving significantly different terms as lenders learn to value cases, which firms need a strong handle on to ensure lending terms do not overwhelm collateral value, says Robert Wilkins at Lightfoot Franklin.
Keys To Regulatory Diligence In Life Sciences Transactions

Conducting effective regulatory due diligence for life sciences deals requires careful review of a target company's activities, and separate sets of considerations for commercial and pipeline products, says Anna Zhao at GunnerCooke.
How Courts Weigh Section 1782 Discovery For UPC Cases

A look at cases from six different federal district courts reveals a number of discretionary factors that influence how courts consider Section 1782 discovery applications in connection with Unified Patent Court proceedings, say attorneys at Finnegan.
Opinion

In Vape Case, Justices Must Focus On Agencies' Results

With the U.S. Supreme Court's ruling in U.S. Food and Drug Administration v. Wages and White Lion Investments having put off the question of whether agency decisions arrived at erroneously are always invalid, the court should give the results of agency actions more weight than the reasoning behind them when it revisits this case, says Jonathan Sheffield at Loyola University Chicago School of Law.
Series

Volunteer Firefighting Makes Me A Better Lawyer

While practicing corporate law and firefighting may appear incongruous, the latter benefits my legal career by reminding me of the importance of humility, perspective and education, says Nicholas Passaro at Ford.
E-Discovery Quarterly: The Perils Of Digital Data Protocols

Though stipulated protocols governing the treatment of electronically stored information in litigation are meant to streamline discovery, recent disputes demonstrate that certain missteps in the process can lead to significant inefficiencies, say attorneys at Sidley.